Dry powder inhalation device

ABSTRACT

Taught herein is a disposable breath actuated dry powder drug inhalation device having a powderized drug storage chamber with integral toroidal geometry and air flow pathways for entraining and breaking up powder aggregates prior to delivery to the patient. The toroidal chamber is fluidly connected by one or more air inlets directed in a non-tangent manner toward the powder to loft and set up an irregular-rotational flow pattern. Also, in fluid connection with the toroidal chamber is a centrally or near centrally located air and powder outlet consisting of one or more holes forming a grid in fluid connection with a channel providing a passageway for powder flow to the patient.

This application claims priority of U.S. provisional application No.61/573,496 filed on Sep. 7, 2011 and is included herein in its entiretyby reference.

COPYRIGHT NOTICE

A portion of the disclosure of this patent contains material that issubject to copyright protection. The copyright owner has no objection tothe reproduction by anyone of the patent document or the patentdisclosure as it appears in the Patent and Trademark Office patent filesor records, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a dry powder inhalation device for theinhalation of pharmaceutical or nutraceutical compounds includingexcipients in dry powder form. More particularly, it relates to a drypowder inhalation device having a toroidal chamber for uniform particalsize delivery to a patient.

2. Description of Related Art

Pressurized metered dose inhalation devices (pMDI) are well-known fordelivering drugs to patients by way of their lungs. pMDI's are comprisedof a pressurized propellant canister with a metering valve housed in amolded actuator body with integral mouthpiece. This type of inhalationdevice presents drug delivery challenges to patients, requiringsignificant force to actuate with inhalation and timing coordination toeffectively receive the drug. pMDI's containing suspended drugformulations also have to be shaken properly by the patient prior toactuating to receive an effective dose of the drug. These relativelycomplicated devices also require priming due to low drug content ininitial doses and can require cleaning by the patient. In some devices,an additional spacer apparatus is prescribed along with the pMDI tocompensate for the timing coordination issue although the downside forthe patient has to pay for, clean, store and transport the bulky spacerapparatus. While many patients are experienced operating pMDI's orpMDI's with spacers, new patients have to go through the relativelysignificant learning curve to operate these devices properly.

Dry powder inhalation devices (DPI) are also well-known for deliveringpowderized drug to the lungs. DPI technologies are either activeinvolving external energy to break-up and aerosolize particles or,passive utilizing the patient's inspiratory energy to entrain anddeliver the powder to the lungs. Some DPI technologies integrateelectronics while others are fully mechanical. The powder drug storageformats are normally reservoir, individually pre-metered doses orcapsule based systems. Drug formulations delivered by these devicesinvolve in some devices innovative engineered drug particles but in mostdevices deliver a conventional blend of sized active pharmaceuticalingredient(s) (API) plus sized lactose monohydrate used as a bulkingagent to aid in the powder filling process and as a carrier particles toaid in delivery of the active pharmaceutical ingredient(s) to thepatient. These API-lactose monohydrate blends among others require ameans to break-up aggregates formed by attractive forces holding themtogether.

Nebulizers are well known for delivering drugs in solution to the lung.While these drug delivery systems are effective for patients lacking theinhalation capability or coordination to operate some hand heldinhalation devices, they are large equipment requiring an electricalpower source, cleaning and maintenance. Administration of nebulizerdrugs involves significant time and effort; transporting, setting upelectrically, loading individual nebules, assembling the patientinterface mouthpiece and delivering doses to the patient.

Inhalation therapies currently being administered in institutionalsettings are either multidose pMDI, multi-dose DPI's or nebulizer all ofwhich demand substantial attention of health care providers toadminister. All current options require substantial effort from thenurse or respiratory therapist to administer, track doses and maintainto meet the needs of the patient. Current options available in theinstitutional setting require the in-house pharmacy to dispensemulti-dose devices that in most devices contain an inappropriate numberof doses relative to the patient's stay and disposal of unused doseswhen patients are released. Additionally, multi-dose inhalation devicesrequiring repeated handling over multiple days in these settingsincrease the chance of viral and bacterial transmission from person todevice to person within the environment. Thus, the complexitiesassociated with the currently available inhalation devices result inconsiderable cost impact to the healthcare system.

Unit dose inhalation devices taught in the art typically involverelatively complicated delivery systems that are relatively heavy,bulky, and costly to manufacture. In addition, most passive dry powderinhalation devices suffer from flow rate dependence issues in which drugdelivery may vary from low to high flow rates. Some devices requiresubstantially low pressure to be generated by the patient to operateproperly and receive the drug effectively. Generating significant lowpressure can be difficult to achieve especially for young and elderlypatients. In many cases, the inhalation device technologically taught inthe art does not provide adequate feedback features to inform thepatient or health care provider if, 1) inhalation device is activatedand ready for use, 2) powderized drug is available for inhalation, 3)powderized drug has been delivered, or 4), and Inhalation device hasbeen used and is ready to be disposed of.

In US 2012/0132204 (Lucking, et al.), there is described an inhalationdevice with a simple flow-through powderized drug storage chamber. Inthis device, air flows through the air gap present after the activationstrip is removed from the rear of the inhalation device. Air flows in anon-specific flow pattern to entrain the powderized drug and deliver itstraight through the inhalation device and to the patient. The amount ofair and resistance of air flow entering the drug storage chamber issusceptible to sink and flatness irregularities in the molded or formedcomponents and compressive forces applied by the patient's hand whileoperating the inhalation device. Powderized drug is not cleared from thepowder storage chamber with a controlled flow pattern leaving thepotential for flow dead zones, powder entrapment and drug deliveryperformance variability especially across a range of flow rates from lowto high, 30 L/min to 90 L/min for example. There is no specificallydesigned means for deaggregating powderized drug besides the flowtransition from the powder storage chamber to the fluidly connectedchannel.

A second embodiment is described with a circulating spherical beadpowder dispersion chamber separate and downstream from the powderstorage chamber. This embodiment involves more complication with movingbeads acting as a mechanical means to grind, and break up powderaggregates as part of the dispersion process. The separate chambers andfluidly connected channel create relatively high surface area forpowderized drug including the finer respirable particles to attach andfail to emit from the inhalation device. The circulating beads aredriven by air flow generated by the patient which can vary dramaticallyhaving an effect on performance with such inhalation driven mechanisms.In addition, these types of mechanisms require substantial low pressureto be generated by the patient to actuate.

In U.S. Pat. No. 6,286,507 (Jahnsson, et al.), there is described aninhalation device with a simple powder storage chamber separate from thepowder deaggregation means which is located in the fluidly connectedchannel. Having these two design elements separate creates significantdevice-drug contact surface area and the potential for substantial drughold-up due to finer more respirable particles with less mass andmomentum attaching to the contact surfaces. In addition, the activationstrip is removed from the rear of the device, not providing mouthpieceobstruction and obvious indication to the patient that the device needsto be activated.

BRIEF SUMMARY OF THE INVENTION

There is a need to have a safer, more efficient, and more cost effectiveoption for delivering inhalation therapies than is currently available.The present invention fulfils that need by providing a dry powderinhalation device for the inhalation of a pre-metered amount ofpharmaceutical or nutraceutical dry powders, including single andmultiple active ingredient blends and excipients designed to address,but not limited to, the aforementioned unmet needs while providingconsistently safe and effective pulmonary drug delivery. Examples ofapplications for use are, but not limited to; meeting the needs ofinfrequent users, delivery of vaccines, drug delivery in institutionalsettings and drug delivery for bio-defense or any other applicationswhere delivery of a dry powder is necessary or desired.

Some of the advantages of using the disclosed inhalation device over theother alternatives are; drug stability by use of a protective overwrapfor each individual dose, easily bar coded or pre-bar coded, intuitive,easy to administer and use, minimal size and weight, efficient dosedelivery, low air flow resistance, simple construction, low cost tomanufacture, disposable, minimizes human cross contamination such asviral or bacterial, consisting of minimal materials reducing theenvironmental impact, reliable operation without moving parts andmechanisms, visual dose delivery indicator, visual inhalation devicereadiness indicator, no coordination required, no cleaning required, nomaintenance required, dose advancement is not required, electricalenergy source is not required, propellant is not required, capsulehandling is not required, dose counter is not required, multi-dosedeterrent is not required, mouthpiece cover is not required, it ismodular and may be packaged as multiple inhalation devices, may bepackaged as multiple inhalers each with different drug formulations, oneinhalation device may contain two toroidal chambers with two differentdrug formulations.

Accordingly, in one embodiment the present invention is a metered doseinhalation device for inhalation of a dry powder by a patientcomprising:

-   -   a) a body having an exterior and an interior;    -   b) a toroidal disaggregation chamber in the interior of the body        having a bottom portion wherein the dry powder is sealed within        at least a portion of the toroidal chamber by a removable        partition wherein when the partition is removed the dry powder        is delivered to the entire toroidal chamber;    -   c) at least one air intake passage in fluid communication with        the exterior of the body and the interior of the toroidal        chamber which directs inlet air toward the bottom of the        toroidal chamber at a non-tangential angle when the partition is        removed; and    -   d) an exit passageway in fluid communication with the exterior        of the body and the interior of the toroidal chamber when the        partition is removed such that upon the inhalation by the        patient on the exit passageway, air is drawn from the air intake        passage to the toroidal chamber to the exit such that dry powder        is carried out the exit passageway to the patient.

Accordingly, in another embodiment of the present invention, there is ametered dose inhalation device for inhalation of a dry powder by apatient comprising a toroidal disaggregation chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overview of the invention depicting its main elements suchas body, channel, air intake passages, air outflow passages, drug flowand toroidal chamber.

FIG. 2 presents a detailed view of the air intake passages, internal airand drug flow and function of the toroidal chamber.

FIG. 3 presents the assembly of the channel component to the inhalationdevice body with the living hinge in the open state.

FIG. 4 presents the inhalation device with the living hinge in the openstate and drug filled into the toroidal chamber.

FIG. 5 presents the inhalation device with the living hinge in the openstate and drug filled into the toroidal chamber and activation strippositioned over the seal or attachment area around the toroidal chamber.

FIG. 6 presents the inhalation device body being closed and the attachedactivation strip being folded with the drug contained within thetoroidal chamber.

FIG. 7 presents the inhalation device with drug contained within thetoroidal chamber, activation strip sealed and folded and perimeter ofthe device body sealed or joined.

FIG. 8 presents a different perspective view of FIG. 7.

FIG. 9 presents a different perspective view of FIG. 7.

FIG. 10 is an illustration of use of the inhalation device includingprotective overwrap.

FIG. 11 presents an example of a multi-dose embodiment with multipledoses of the same drug available for inhalation.

FIG. 12 presents an example of a multi-dose embodiment with differentdrugs available for inhalation.

FIG. 13 presents orthogonal views.

FIG. 14 presents a detailed cross section of the toroidal chamberillustrating key features.

FIG. 15 is a cross section side view illustrating a serpentine inlet,drug spillage, inlet air flow and bypass and outlet air flow.

FIG. 16 is a cross section side view illustrating an air inlet, inletair flow and bypass and outlet air flow.

FIG. 17 illustrates drug flow from the toroidal chamber, through theoutlet grid-toroidal chamber interface and through the channel for exitto the patient.

FIG. 18 presents drug powder filling into inhalation devices by use of acommon ‘drum’ filling system.

FIG. 19 presents a front view of the inhalation device with one rigidbody member and one conformable, forced and attached during assembly toreduce the air gap between the two body members.

FIG. 20 presents an alternate full toroidal chamber embodiment.

FIG. 21 presents orthogonal and sectional views of an alternate fulltoroidal chamber embodiment.

DETAILED DESCRIPTION OF THE INVENTION

While this invention is susceptible to embodiment in many differentforms, there is shown in the drawings, and will herein be described indetail, specific embodiments, with the understanding that the presentdisclosure of such embodiments is to be considered as an example of theprinciples and not intended to limit the invention to the specificembodiments shown and described. In the description below, likereference numerals are used to describe the same, similar orcorresponding parts in the several views of the drawings. This detaileddescription defines the meaning of the terms used herein andspecifically describes embodiments in order for those skilled in the artto practice the invention.

Definitions

The terms “about” and “essentially” mean±10 percent.

The terms “a” or “an”, as used herein, are defined as one or as morethan one. The term “plurality”, as used herein, is defined as two or asmore than two. The term “another”, as used herein, is defined as atleast a second or more. The terms “including” and/or “having”, as usedherein, are defined as comprising (i.e., open language). The term“coupled”, as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

The term “comprising” is not intended to limit inventions to onlyclaiming the present invention with such comprising language. Anyinvention using the term comprising could be separated into one or moreclaims using “consisting” or “consisting of” claim language and is sointended.

Reference throughout this document to “one embodiment”, “certainembodiments”, and “an embodiment” or similar terms means that aparticular feature, structure, or characteristic described in connectionwith the embodiment is included in at least one embodiment of thepresent invention. Thus, the appearances of such phrases or in variousplaces throughout this specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments without limitation.

The term “or” as used herein is to be interpreted as an inclusive ormeaning any one or any combination. Therefore, “A, B or C” means any ofthe following: “A; B; C; A and B; A and C; B and C; A, B and C”. Anexception to this definition will occur only when a combination ofelements, functions, steps or acts are in some way inherently mutuallyexclusive.

The drawings featured in the figures are for the purpose of illustratingcertain convenient embodiments of the present invention, and are not tobe considered as limitation thereto. Term “means” preceding a presentparticiple of an operation indicates a desired function for which thereis one or more embodiments, i.e., one or more methods, devices, orapparatuses for achieving the desired function and that one skilled inthe art could select from these or their equivalent in view of thedisclosure herein and use of the term “means” is not intended to belimiting.

As used hereinafter, the terms “device”, “device of the presentinvention,” “present inhalation device,” “inhaler” or “inhalationdevice” are synonymous.

As used hereinafter, the terms “body”, “case” and “housing,” aresynonymous and refer to the inhalation device as a whole. The body hasan exterior and an interior portion.

As used herein the term “inhalation device” refers to a device where apatient inhales on the device to draw a dry powder into the patient.Typically, this is done to draw a medicament into the lungs of thepatient. In one embodiment, the device is constructed for a single use.

For the purpose of this disclosure, the term ‘deaggregation’ issynonymous with deagglomeration and disaggregation describing thebreak-up of like or unlike particles In form a more uniform suspensionof the powder in a stream of air.

As used herein a “toroidal disaggregation chamber” refers to a chamberhaving a toroidal shape. In general, in one embodiment that is a torusshape but any general toroidal shape such as tapered squared or the likewill work in the present invention. The chamber is positioned on theinterior of the body of the device. Sealed within the chamber, in just apartition of the chamber, is a dry powder. The powder is sealed in placeby a removable partition. The partition separates the rest of thechamber from the dry powder such that when the partition is removed thedry powder is exposed to the entire toroidal chamber.

As used herein the “removable partition” or “activation strip” is adevice that holds the dry powder within a portion of the device suchthat when the partition is removed the dry powder can move to the entireinterior of the toroidal chamber. In one embodiment the partition has atab which can be pulled from the exterior of the body to remove thepartition. The removable partition or activation strip may be made ofthe following materials: Peelable aluminum foil structure, foilstructure, polymer film or polymer laminate, cellulose, celluloselamination, wax coated, biodegradable or compostable materials.

As used herein the “air intake passage” refers to an air inlet in fluidcommunication to the air on the exterior of the device to the interiorof the toroidal disaggregation chamber. Air entering the air intakepassage is delivered to the toroidal chamber. In an embodiment, theinlet air is aimed at a non-tangential angle for example at an angletoward the bottom of the toroidal chamber. In the present inventionthere is at least one and in another embodiment there are two. In yetanother embodiment, there are two opposing air intake passages. In yetanother embodiment the passages are on the same side of the body.

As used herein an “exit passageway” is a passage in fluid communicationwith the exterior of the body and the interior of the toroidal chambersuch that upon the inhalation by the patient on the exit passageway, airis drawn from the air intake passage to the toroidal chamber to the exitsuch that dry powder is carried out the exit passageway to the patient.In one embodiment, the exit passageway widens as it exits the devicebody. In another embodiment, it widens sufficiently for a patient toplace their mouth on the exit for inhalation of the powder within thetoroidal chamber. In one embodiment the exit passageway has air flowchannels.

For the purpose of this disclosure, the term ‘drug’ includes bothpharmaceutical and nutraceutical compounds including any formulationsincluding excipients. All mentions of ‘drug’ refer to powderized drug.

For the purpose of this disclosure, the term ‘powder’ is synonymous withpowderized drug and includes both pharmaceutical and nutraceuticalcompounds including any formulations including excipients.

pMDI is a pressurized metered dose inhaler designed to deliver drugs bymetering doses from a propellant filled reservoir and aerosolizing dosesby release of the propellant energy.

DPI is a dry powder inhaler designed to deliver powderized drugs to thelung either passively using only the patient's inspiratory effort oractively utilizing an external energy source along with the patient'sinspiratory effort to disperse and deaggregate powderized drug.

The disposable breath actuated dry powder drug inhalation device has apowderized drug storage chamber integral to a toroidal chamber and airflow pathways for entraining and breaking up powder aggregates prior toinhalation of the powder by the patient. The toroidal chamber is fluidlyconnected by one or more air inlets directed in a non-tangent mannertoward the powder to loft and set up an irregular-rotational flowpattern. Also in fluid connection with the toroidal chamber is acentrally located air and powder outlet consisting of one or more holesforming a grid or hole in fluid connection with a channel providing apassageway for drug flow to the patient. Upon actuation of theinhalation device by breath induced low pressure from the patient, inletair enters the toroidal chamber causing powder aggregates with greatermass and centrifugal force to circulate toward the outer was for greatertime duration than smaller particles. The first stage of impact forcesare applied to powder aggregates as they collide with each other and thewas of the toroidal chamber. Additionally, a second stage of forces areapplied to powder aggregates as they flow through the intersectingirregular-rotational and non-tangent inlet airstreams subjectingparticles to air shear forces, velocity and directional changes. Theresulting powder is partially deaggregated and these smaller particleswith less mass and centrifugal force flow to the chamber outlet whereadditional third stage impact forces are applied due to collisions withthe outlet grid or hole structure and particle bounce between thetoroidal chamber-outlet grid or hole interface (“interface”). In oneembodiment, the chamber outlet is centrally located. Deaggregatedpowderized drug then flows from the outlet grid or hole through thefluidly connected channel to the patient.

Now referring to the drawings, FIGS. 1 and 2 depict a perspective viewof an embodiment of the present invention with FIG. 2 showing a moredetailed perspective view. This embodiment in FIG. 1 is an inhaler withthe removable partition removed 115. This is the device in use since,with the partition in place; the device is designed for storage untiluse. The inhaler 115 consists of a body which, in this embodiment,consists of an upper inhaler body 80 and a lower inhaler body 65. Thisinhaler has an exterior with the mechanics disposed on the interior ofthe device. In use, a patient would place their mouth over the areawhere air exits the inhaler 115. This is indicated by bypass air flowchannels 20 and powderized drug and airflow channel 25 both of whichdeliver to the patient when the patient inhales. Upon inhalation, airenters the air intake passage 5 and travels downward at an angle in anon-tangential manner 10 and into the toroidal chamber 60 which is shownin this figure as a circle, a 3D view will be seen in other figures.This embodiment has two air intake passages 5 which are positioned onthe top 80 of inhaler 115. Air swirls in the toroidal chamber 60 andswirls dry powder (not shown in this view) breaking up any agglomeratesof power until air and powder exit through outlet grid 75 to create afluid communication of the drug and air flow with exit passageway formedby component 40. Aerosolized powder enters an area of exit passageway in40 wherein there are multiple passage channels. Airflow regulatoropenings 15 allow air flow resistance tuning by sizing the openings toregulate how much air passes through channels 20 and main channel 25with delivering the powder exiling from main channel 25. Sizing of thepowder exit 75 the holes providing entry of regulator flow 15 determinesthe air flow resistance level and therefore, the inspiratory effortrequired to inspirationally actuate the inhaler 115. The preferredembodiment includes a mechanical stop integrated into the inhalationdevice body providing a stop point for insertion into the patient'smouth thereby providing indication to the patient that the appropriateengagement depth has been achieved to safely and effectively operate theinhalation device by breath actuation.

FIG. 2 shows this airflow/drug flow in a dose up perspective view of theinhaler 115. Because bigger aggregated particles will tend to flowaround the outer circumference 200 of the toroidal chamber 60, they aresubjected to impact forces and break up before flowing to the outletgrid 75. As shown in FIG. 2, the toroidal chamber 60 is designed toutilize the centrifugal force of irregular-rotationally flowing powderaggregates with relatively large mass to partially break-up by impactingeach other and the walls of the toroidal chamber yielding finerparticles with reduced mass and centrifugal force. Additionally, asecond stage of forces are applied to powder aggregates as they flow 200through the intersecting irregular-rotational and non-tangent inletairstreams 10 subjecting particles to air shear forces, velocitychanges, directional changes, and particle-to-particle collisions.Smaller drug aggregates or particles with reduced mass and centrifugalforce may then flow to the toroidal chamber outlet grid or holeinterface 75. As particles begin to get smaller due to the forces insidethe toroidal chamber 60 they move closer and closer toward the outletgrid 75 near the center of the toroidal chamber 60 till they exit thegrid 75 and enter the airflow pathway 25 in the exit passageway ofcomponent 40.

FIGS. 3 through 9 depict a perspective view of the construction of aninhaler with the activation strip 95. FIG. 3 depicts the inhaler bodymolded from a single piece of material the exterior of the body top 80and exterior bottom 65 are shown in this view. The toroidal shape of thetoroidal chamber 60 can clearly be seen in this view. The exitpassageway component 40 is mounted on the exterior of upper side 80creating the bypass channels 30 and drug/air channel 35. The bypass airholes 45 are shown in this view. The upper 80 and lower 65 body arejoined by a living hinge 70, a molded strip, such that the upper 80 andlower 65 portions of the body are molded as one piece.

FIG. 4 shows the interior surface of upper body 80 and lower body 65.Clear in this view is the interior surface of the toroidal chamber 60showing powder 85 in the chamber 60. Because the removable partition isnot added, the powder merely sits in the bottom of chamber 60. Anattachment area 90 for the partition is shown which can include anadhesive material for adhering a partition.

In FIG. 5 a partition 95 is placed on the interior surface of bodyportions 80 and 5 covering entirely toroidal chamber 60 from deliveringpowder to the flow pathway of the inhaler. FIG. 6 shows the folding 100of the upper body 80 to meet the lower body 65 folding the removablepartition. In FIG. 7 an embodiment of the present invention inhaler iscompletely constructed and noted as inhaler 110 in the followingfigures.

FIG. 8 depicts a perspective view of the same inhaler 110 as shown inFIG. 7 however, from a different view which allows a view of the exitpassageway of the inhaler 110. FIG. 9 shows a bottom perspective view ofinhaler 110.

FIG. 10 is a perspective series of views of opening, removal of thepartition and use of inhaler 110 in a single use embodiment. Anembodiment of the present inhalation device 110 as shown in FIG. 10 isprotected from contamination, ultraviolet light, oxygen, if required,and water vapor ingress by a surrounding protective overwrap 105 suchas, but not limited to, aluminum foil laminates joined to contain theinhalation device as individually packaged or joined in a strip, sheet,or roll form with individually removable inhalation devices by shearingor pulling apart for as-needed access to inhalation devices frommulti-dose package. In addition, either of the aforementioned protectiveoverwrap packaging configurations providing printable area for colorcoding and bar coding for scanning into electronic charting systems andproviding general information to patients and administrators.

As shown in FIG. 10, the preferred embodiment requires, but is notlimited to, a minimal number of steps as disclosed below to administeror self administer the dry powderized drug.

-   -   open the protective overwrap 105 packaging    -   pull the activation strip 95 by the end and remove it    -   have the Patient Inhale 125 the powderized drug    -   dispose 135 of the inhalation device and protective overwrap

This embodiment of the inhalation device may be disposed of after use tohelp facilitate dean environments of use or administration by reducingthe chance of person to device to person transmission of hazardousmatter such as viruses and bacteria.

As shown in FIG. 10, patient feedback inhalation device statusindicators include the obstruction of the mouthpiece by the activationstrip because of its length in the assembled state 110, providingindication to the patient that activation strip 95 removal is requiredprior to inhaling 125 the powderized drug. The indicators also includethe use of transparent materials for the inhalation device body orpowder storage chamber providing visibility of the drug before and afteruse for confirmation of drug delivery by visual inspection 130. In FIG.10, 105 depicts the protective overwrap, 110 shows the device removedfrom the protective overwrap, 115 depicts the inhalation device with theactivation strip 95 removed and drug ready for inhalation, 125 arrowillustrates breath actuation by the patient 125 and 135 representsdisposal of the used inhalation device.

An additional embodiment is a multi-dose strip as shown in FIG. 11comprised of inhalation devices integrated and packaged as one with eachtoroidal chamber containing the same powderized drug formulation 140drug “A”.

An additional embodiment is a multi-dose strip as shown in FIG. 12comprised of inhalation devices integrated and packaged as one. One sideof the inhalation device may contain powderized drug “B” 145 and theother side powderized drug “C” 150 as well as additional drugs.

An additional embodiment includes multiple inhalation toroidal chambersfluidly joined to one powder exit passageway and patient interfacemouthpiece. Each toroidal chamber may contain different powderizeddrugs.

FIG. 13 depicts a series of orthogonal views of inhaler 110.

FIG. 14 depicts a series of views of embodiments including an activationstrip 95 designed to retain and protect the powderized drug in thetoroidal chamber by closing off a region of the chamber (and in someembodiments the entire chamber). Removal of the activation strip 95“activates” the inhalation device exposing and fluidly connectingpowderized drug 85 residing in the toroidal chamber 60 to one or moreinlet airways 55 and outlet grid or hole 75. This prepares theinhalation device 115 for dose delivery to the patient when low pressurebreath actuation (inhalation) occurs. The activation strip 95 may beremovable from the inhalation device and disposed of separately. Theaforementioned design is useful due to its simplicity and intuitivenessfor the user. An alternate embodiment may include a shifting activationstrip. In this embodiment, shifting or moving the activation strip fromone position to another activates the inhalation device 115 whileremaining retained within the inhalation device 115. The activationstrip may be assembled or joined, but not limited, to the followingmethods; heat sealing, captured in place mechanically, adhesive,peelable adhesive, friction fit, press fit, snap fit, laser welded,radio frequency or ultrasonic welding. It may be assembled or joined tothe inhalation device with or without folds. Folding 100 the activationstrip 95 along with the inhaler body during assembly as shown in FIG. 6results in a peelable attachment to facilitate activation by shearingthe peelable bond area 90 FIG. 5 between the activation strip andinhalation device body. The activation strip 95 may provide printablearea for color coding and bar coding for scanning into electroniccharting systems and providing general information to patients andadministrators.

As shown in FIG. 14, the embodiment includes an integrated toroidalpowderized drug storage and deaggregation chamber 60 designed to retainand protect the powder 85 during storage and provide the means todeaggregate the powder during the breath actuation event. The toroidalchamber 60 design is an improvement over the prior art due to itsreduced powder-inhalation device contact surface area, reducing powderhold-up (losses) in the device, controlled and efficient air and drugpath and simplified construction. Integration of the powder storagechamber and deaggregation chamber into one simplifies inhalation devicedesign and reduces powder to inhalation device contact surface arearesulting in reduced powder losses and therefore improved drug deliveryperformance. The toroidal chamber consists of an outside wall 265,inside wall 260, outlet grid or hole 75 interface region which is theair gap between 75 and 155 bottom and top surfaces.

In FIG. 14 the toroidal chamber geometry includes a raised central axislocated region 270 that guides drug particle flow to the chamber outletgrid or hole 75 eliminating an air flow dead zone at the bottom of thechamber where powder 85 would normally collect and fail to be deliveredto the patient. The flow pattern within the toroidal chamber 60 isirregular and not a truly circular path due to the intersectingnon-tangent inlet air streams 10 disrupting circular flow and modifyingthe flow path into an irregular-rotational path.

The following is applicable to both toroidal and full torus chambers;for the purpose of illustration in this disclosure, the toroidal chamberincluding inner (example 260, FIG. 14) and outer surfaces (e.g. 265,FIG. 14) is shown as various circular toroidal geometries howeverembodiments are not limited to circular. Additional geometries may beused such as polygonal, polygonal with radiused corners, oval,elliptical or irregular or any combination thereof applied to inner andouter surfaces of the toroidal chamber.

Inlet air 10 may be guided through channel(s) 55, 120 as shown in FIG.15 with redirected pathway(s) creating a holding area(s) 120 for powderin the event, after activation the inhalation device is tilted to theextent drug powder 85 spills into any of the air inlets prior to breathactuation of the inhalation device. The redirected pathway(s) as shownin FIG. 15 prevent powder loss when the inhalation device is tilted andretains powder in the holding area(s) 120 for entrainment and flow tothe patient during the breath actuation.

In FIG. 16 upon inhalation, inlet air 10 rushes into the toroidalchamber 60 lofting and flowing the powderized drug 85. The non-tangentinlet air flow paths 10 intersecting the fluidly connected toroidalchamber 60 creates relatively high air flow velocity regions,redirecting the circulating powderized drug 85 into anirregular-rotational flow pattern. This intersection of the air flowpaths provide air shear forces, velocity and directional changes toflowing particles further deaggregating the powderized drug 85. Inletair may be guided through channels 55 with the geometry designed todirect flow non-tangentially toward the powder or elsewhere to achievethe desired drug delivery performance.

FIG. 17 depicts where the powder is subjected to additional third stageimpact forces as the drug aggregates 205 impacts the rigid surfaces inthis air gap region and bounce between the interface surfaces.

In FIG. 17 the embodiment includes an outlet grid or hole 75 fluidlyintersecting the toroidal chamber 60 near its center axis providing anopening or openings for flowing powderized drug 205, 165 to exit thetoroidal chamber 60 and flow through the fluidly connected channel 35 tothe patient. The outlet grid 75 may consist of round holes or any of thefollowing polygonal, radiused polygonal, oval, elliptical, ribbed,stepped, convex, concave, tapered holes, vents, staggered layout, linearlayout, radial layout, radial openings, a mesh, a screen, irregular andany combination or reasonable variants thereof. The outlet grid 75 maybe substituted with a single hole 75 sized and located to facilitateoutlet flow of drug powders with flow properties, particle size andcohesiveness for optimizing drug delivery performance. The single outlethole 75 may be round, polygonal, radiused polygonal, ribbed, stepped,convex, concave, oval, elliptical, tapered, irregular and any reasonablevariant thereof. The outlet flow area is the air and powder flowthrottle point of the drug flow passageway in the inhalation device. Adesign feature is the adjustment of the outlet flow area that deter lesthe air volume, air flow velocity, drug powder impact forces andduration of air flow through the toroidal chamber 60. The outlet flowarea is equal to the sum of the area of all holes in the grid or thesingular hole area. As shown in FIG. 17, the outlet grid structure 75including solid partitions or ribbing between and around the outlet gridopenings, impart impact forces on the powderized drug as rotationallyflowing powder aggregates 205, 165 are forced through the stationarygrid. Additionally, the singular outlet hole 75 transition impartsimpact forces on the powderized drug as rotationally flowing drugaggregates 205 impact the top surface of the chamber prior to exiting tothe fluidly connected channel.

As shown in FIG. 17, an embodiment includes an outlet grid orhole-toroidal chamber interface air gap region formed between surfaces75, 155 and consisting of an outlet grid or hole 75 and a raisedtoroidal chamber section 270 with internal surface 155. The air gapformed by this interface defines a region where powderized drug isforced to flow through path 165 during the breath actuation event due tothe low pressure differential generated by the patient. Flowing drugparticles 165 trying to exit are of various particle size with differingdegrees of aggregation. The smaller particles are able to redirect andflow through the outlet opening(s) of 75 while the larger particles withgreater mass and momentum impact the solid grid structure of 75 and thesurface around the opening. This impact imparts forces on the aggregateddrug particles to break them up into smaller more respirable drugparticles. The impacting particles are free to bounce back and forth(path 165) in the air gap region between the outlet grid or hole 75 andthe raised section of the toroidal chamber 155. The particle bounceeffect (path 165) applies additional impacts to the aggregated particlesprior to exiting to the fluidly connected channel 35 and flowing to thepatient. The geometry of the outlet grid or hole-toroidal chamberinterface 75, 155 may consist of many variants. The embodiments are notlimited to specific interface geometries but some examples include:point, dome, hemispherical, flat, cone, convex, concave, cylindrical,irregular, conic, stepped and irregular shapes including any combinationthereof.

In FIG. 18, the living hinge 70 location on the front or rear surfacesof the inhalation device creates a narrow profile while in the openstate for efficiently filling powderized drug into multiple inhalationdevices at one time. Each rotation 190 of a powder filling system's‘drum’ 175 with multiple dosing bores 170 may fill a greater number ofinhalation devices 185 per cycle as compared to inhalation devices witha living hinge on a side surface. Due to the living hinge feature 70,additional manufacturing efficiencies may be achieved such as reduced;tooling, handling, automation equipment and supply chain management.FIG. 18, 180 depicts drug powder filling into the empty inhalationdevices in the flat state 185 and 195 depicts linear indexing ofinhalation devices 185 between filling cycles. An alternate embodimentmay be constructed without the living hinge 70 as disclosed above. Theinhalation device may be comprised of components produced and assembledas individual body components; the separate upper body component 80 andseparate lower body component 65.

As shown in FIG. 19, this embodiment includes a means for ensuring airgap closure or minimization between the inhalation device body halves byproducing one side convex 240 and the opposite side 245 flat or of adifferent convex or concave radius. During assembly, the two body halvesare forced 250 together and joined along the perimeter area 255conforming the two body halves 65 and 80 to each other to reduce the airgap(s) in between due to component dimensional irregularities such assink and warp. The built-in force biasing the two inhalation device bodyhalves 65 and 80 to each other in the assembled state also acts toretain the activation strip 95 and dose the activation strip gap afteractivation thereby preventing air leakage and powder loss in the gap.

As shown in FIGS. 20 and 21, an alternate embodiment 160 may include anintegrated full torus powderized drug storage and deaggregation chamber215 designed to retain and protect the powder 85 during storage andprovide the means to deaggregate the powder prior to delivery to thepatient. Integration of the powder storage chamber and deaggregationchamber into one simplifies inhalation device design and reduces drugpowder to inhalation device contact surface area resulting in reduceddrug powder losses and therefore improved drug delivery performance. Thefull toroidal chamber consists of a full toroidal shape with outsidewall, inside wall, outlet grid or hole 225 interface region, bottomsurface, top surface and intersecting channel. The full toroidal chamber215 is designed to utilize the centrifugal force ofirregular-rotationally flowing powder aggregates 200 with relativelylarge mass to partially break-up by impacting each other and the wallsof the full toroidal chamber yielding finer particles 205 with reducedmass and centrifugal force. Additionally, a second stage of forces areapplied to powder aggregates 200 as they flow in a rotational path andimpact the protruding channel 210 subjecting particles to impact forces,velocity changes and directional changes. Smaller powder aggregates withreduced mass 205 and centrifugal force may then flow to the toroidalchamber outlet grid or hole interface 225 where they are subjected toadditional third stage impact forces as the aggregates impact rigidsurfaces in this interface 225 region and bounce between the interfacesurfaces. In addition, the full torus chamber geometry 215 includesraised central axis or near central axis located regions that guideparticle flow to the chamber outlet grid or hole 225 eliminating the airflow dead zones at the top and bottom of the chamber where drug powder85 would nor ally collect and fail to be delivered to the patient. Theflow pattern within the full torus chamber 215 is irregular and not acircular path due to the intersecting channel disrupting circular flowand modifying the flow path into an irregular path. One or more airinlets 55 may be used fluidly connected and intersecting the fulltoroidal chamber 215 either tangentially or non-tangentially. In FIGS.20 and 21, 220 and 230 are inhalation device body components and 235 isthe channel outlet fluidly connected through channel component 210 tothe outlet hole or grid 225.

The inhalation device may be made from the following materials forexample including injection molded polymers, anti-static polymers,thermoformed or pressure formed polymers, cellulose (paper) or partialcellulose laminated material, wax coated laminates, biodegradable,compostable, elastomers, silicone, aluminum foils including laminations,metallic hot or cold formed, glass, ceramic and composite materials orany combination thereof.

The inhalation device components maybe produced by the followingmanufacturing methods: injection molding, thermoforming, pressureforming, blow molding, cold forming, die cutting, stamping, extruding,machining, drawing, casting, laminating, glass blowing.

The inhalation device components may be joined by the following methods:heat sealing, heat staking, ultrasonic welding, radio frequency welding,snap fits, friction fits, press fits, adhesive, heat activated adhesiveand laser welding or any combination thereof.

The outlet grid or hole region may be made from the following materials:polymers, anti-static polymers, metal, metal mesh or screen, elastomers,silicone, cellulose, glass, ceramic, wax coated laminations, aluminumincluding foils and foil laminations, biodegradable and compostable orany combination thereof.

The embodiments reside as well alone or in sub-combinations of theobjects, aspects, elements, features, advantages, indicators, methodsand steps shown and described.

It is an object of all embodiments to provide an improved disposable drypowder inhalation device for pulmonary inhalation of pharmaceutical ornutraceutical dry powders including excipients.

The embodiment or embodiments including any sub-combinations of theobjects, aspects, elements, features, advantages, indicators, methodsand steps may be used in any type of patient in any setting for anytherapy in any orientation.

The embodiment or embodiments including any sub-combinations of theobjects, aspects, elements, features, advantages, indicators, methodsand steps may be used in a multi-dose inhalation device with a separateindex-able drug strip or cartridge or replaceable drug blister orcapsule.

The embodiment or embodiments including any sub-combinations of theobjects, aspects, elements, features, advantages, indicators, methodsand steps may be used in a nasal drug delivery device.

The embodiments including any sub-combinations of the objects, aspects,elements, features, indicators, advantages, methods describes theinhalation device and method for pulmonary inhalation of pharmaceuticalor nutraceutical dry powders including excipients.

The embodiments are not limited to the specifics mentioned as many otherobjects, aspects, elements, features, advantages, methods and steps andcombinations may be used. The embodiments are only limited only by theclaims. Additional information describing the embodiments are stated inother sections of this disclosure.

It should be understood that the embodiments also resides insubcombinations of the objects, aspects, components, features,indicators, methods, materials and steps described.

Those skilled in the art to which the present invention pertains maymake modifications resulting in other embodiments employing principlesof the present invention without departing from its spirit orcharacteristics, particularly upon considering the foregoing teachings.Accordingly, the described embodiments are to be considered in allrespects only as illustrative, and not restrictive, and the scope of thepresent invention is, therefore, indicated by the appended claims ratherthan by the foregoing description or drawings. Consequently, while thepresent invention has been described with reference to particularembodiments, modifications of structure, sequence, materials and thelike apparent to those skilled in the art still fall within the scope ofthe invention as claimed by the applicant.

What is claimed is:
 1. An inhalation device for inhalation of a pre-metered dry powder drugs by a patient comprising: a) a body having an exterior and an interior; b) a toroidal disaggregation chamber in the interior of the body having a bottom portion wherein the dry powder is sealed within at least a portion of the toroidal chamber by a removable partition wherein when the partition is removed the dry powder can be exposed to the entire toroidal chamber; c) at least one air intake passage in fluid communication with the exterior of the body and the interior of the toroidal chamber which directs inlet air toward the bottom of the toroidal chamber at a non-tangential angle when the partition is removed; and d) an exit passageway in fluid communication with the exterior of the body and the interior of the toroidal chamber when the partition is removed such that upon the inhalation by the patient on the exit passageway, air is drawn from the air intake passage to the toroidal chamber to the exit such that dry powder is carried out the exit passageway to the patient.
 2. The inhalation device according to claim 1 wherein there are two opposing air intake passages.
 3. The inhalation device according to claim 1 wherein all the air intake passages are on the same side of the body.
 4. The inhalation device according to claim 1 wherein the exit passageway widens as it exits the body.
 5. The inhalation device according to claim 1 wherein the partition is removed via a pull tab on the exterior of the body.
 6. The inhalation device for inhalation of a dry powder by a patient comprising a toroidal disaggregation chamber.
 7. The inhalation device according to claim 1 wherein the exit passageway has airflow channels leading to the exterior of the body.
 8. The inhalation device according to claim 1 wherein there are air bypass holes for adjusting the airflow through the inhaler.
 9. The inhalation device according to claim 1 wherein there is an outlet grid in the toroidal chamber to create fluid communication between the toroidal chamber and the exit passageway.
 10. The inhalation device according to claim 1 wherein the device further comprises a protective overwrap.
 11. The inhalation device according to claim 1 wherein the removable partition obstructs a mouthpiece before removed.
 12. The inhalation device according to claim 1 wherein at least a portion of the body is transparent.
 13. The inhalation device according to claim 1 wherein the air intake passage is serpentine such that it can retain a spilled powder. 